GUDIDData
gudid Primary ID: 23-005-46

Thermo Scientific Protocol Parasitology System (UDI 23-005-46)

Manufactured by Fisher Diagnostics

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Thermo Scientific Protocol Parasitology System - Primary ID 23-005-46

Device Regulatory Overview

The Thermo Scientific Protocol Parasitology System (Model/Catalog Number: 23-005-46) is a medical device manufactured by Fisher Diagnostics. This product is indexed under FDA Product Code / Category Classification LDY within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1503-2025 View Full Alert →

Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays....

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1502-2025 View Full Alert →

Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-2762-2017 View Full Alert →

Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fish...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
23-005-46
Product Code / EMDN
LDY
Device Name
Database Sync Date
2026-08-09 09:21:10

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Thermo Scientific Protocol Parasitology System?

The registered manufacturer of record for Thermo Scientific Protocol Parasitology System is Fisher Diagnostics.

What is the Primary UDI-DI identifier for Thermo Scientific Protocol Parasitology System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 23-005-46.

What classification code is assigned to this device?

This device is registered under product classification code LDY.

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